NCT07510802RecruitingPhase 1/2
Dual-Target CAR-NK Cells for Advanced Breast Cancer HER2+ TNBC
Phase 1/2, Biomarker-guided, Open-label Study of Allogeneic Dual-target CAR-NK Cells Directed Against HER2/ERBB2, MUC1, and/or ROR1 in Patients With Advanced or Metastatic Breast Cancer (Including HER2-positive and Triple-negative Disease).
Source: ClinicalTrials.gov · Last updated 6 Apr 2026
Brief summary (registry, in English)
This study tests the safety and preliminary anti-tumor activity of an investigational dual-target chimeric antigen receptor natural killer (CAR-NK) cell therapy in adults with advanced breast cancer. After a tumor antigen assessment (HER2/ERBB2, MUC1, ROR1,TNBC cases mesothelin), each participant will receive the most suitable dual-target CAR-NK product for their tumor profile, following short-course lymphodepleting chemotherapy.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 20 Mar 2026
- Start date
- Feb 2026
- Primary completion date
- Mar 2027
- Lead sponsor
- Beijing Biotech
- NCT number
- NCT07510802
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 60
- From Feb 2026 to the primary completion date, Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior gene-modified cellular therapy (e.g., CAR-T or CAR-NK) within 6 months or unresolved grade ≥ 2 toxicity from prior cellular therapy.
- Concurrent participation in another interventional study that could confound safety or efficacy assessments.
Other illness
- Active, untreated central nervous system (CNS) metastases or leptomeningeal disease. Patients with treated CNS metastases may be eligible if clinically stable for ≥ 4 weeks and off high-dose steroids.
- Clinically significant active autoimmune disease requiring systemic immunosuppression (physiologic steroid replacement permitted).
- Uncontrolled infection, including uncontrolled HBV, HCV, or HIV infection (controlled infections may be eligible per investigator).
- History of severe hypersensitivity to fludarabine or cyclophosphamide.
- Any condition that, in the investigator's judgment, would make the participant unsuitable for the study (e.g., uncontrolled comorbidity, inability to comply with protocol procedures).
Other
- Pregnant or breastfeeding.
Who the study is looking for
- Histologically confirmed breast carcinoma that is locally advanced, unresectable, or metastatic.
- Disease subtype: HER2-positive breast cancer or triple-negative breast cancer (TNBC).
- Progression after, intolerance to, or ineligibility for standard therapies appropriate for the disease subtype and line of therapy.
- At least one measurable lesion per RECIST v1.1.
- Tumor antigen assessment available (fresh or archival): expression of at least one candidate target antigen (HER2/ERBB2, MUC1, or ROR1). For TNBC, mesothelin assessment may be performed for exploratory analyses.
- ECOG performance status 0-1.
- Adequate organ function (example thresholds): ANC ≥ 1.0 x 10\^9/L; platelets ≥ 75 x 10\^9/L; hemoglobin
- 8 g/dL; AST/ALT ≤ 3x ULN (≤ 5x with liver metastases); total bilirubin ≤ 1.5x ULN; creatinine clearance
- 50 mL/min.
- Left ventricular ejection fraction (LVEF) ≥ 45% and no uncontrolled cardiac arrhythmia.
- Negative pregnancy test for participants of childbearing potential; agreement to use effective contraception during study treatment and for 6 months after last CAR-NK infusion.
- Ability to understand and willingness to sign informed consent.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Shenzhen Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.